Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-24 @ 2:43 PM
NCT ID:
NCT00055159
Eligibility Criteria:
* INCLUSION CRITERIA:
Adults (18 years or older) are eligible for this study.
Patients must be enrolled in or actively being evaluated for a protocol at the Clinical Center.
Patient must be able to give informed consent and be able to follow anticoagulation regimen if enrolled.
Occlusive thrombosis of jugular, axillary, subclavian, or brachiocephalic veins must be documented by ultrasound, or venography (Occlusive meaning complete blockage of blood flow across affected venous segment). Although most thrombi will be associated with a VAD, this is not a requirement.
Estimated duration of thrombosis should not exceed 4 weeks based on clinical history.
Postpartum mothers are eligible for this treatment, but nursing mothers will be instructed to refrain from breast feeding their infants for 24 hours after each venogram or contrast study.
EXCLUSION CRITERIA:
Pregnancy: Although the abdomen can be shielded from medical radiation required for the procedures, the use of contrast media, thrombolytic enzymes, and anticoagulation can potentially have adverse effects on a pregnancy, so that thrombolytic therapy is contraindicated during pregnancy.
Children are excluded from this protocol but are eligible for the high dose regimen that is the current standard at NIH.
Patients who are cognitively impaired and cannot give consent will not be eligible for this protocol. The current high dose regimen remains an option, if appropriate consent can be obtained from legally responsible guardian or family member.
Patients with known diabetic or other retinopathy will be excluded unless cleared for treatment by an ophthalmologist.
Gastrointestinal or internal bleeding (except microscopic hematuria) within the previous two weeks; active peptic ulcer disease; familial or acquired bleeding diathesis not attributable to heparin administration (prothrombin time greater than 14 s, APTT greater than 35s, fibrinogen less than 150mg/dl); thrombocytopenia less than 50,000 microliters.
History of cerebrovascular accident or neurosurgery within previous 2 months
Lumbar puncture within previous 2 weeks, or patients with epidural catheters, current or in the past 2 weeks.
Major surgery, trauma, or deep organ biopsy within the previous 10 days: recent onset (less than 10 days) of atrial fibrillation without anticoagulation, Known right to left cardiac shunts, and pulmonary arteriovenous malformations.
Severe hypertension (systolic pressure greater than 200 mmHg, diastolic pressure 110 mmHg)
Renal insufficiency with serum creatinine greater than 2.5mg/dl
History of anaphylactic reaction to iodinated contrast material.
History of heparin-induced thrombocytopenia.
Acute Pericarditis
Known defect of cardiac septum with right to left intracardiac shunt.
Pulmonary arteriovenous malformation.
Bacterial endocarditis.
Intracranial neoplasm, arteriovenous malformation, and aneurysm with evidence, clinically or by imaging, of hemorrhage in previous 2 months excludes participation. If there has been no evidence of bleeding, these patients can be considered for participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00055159
Study Brief:
Protocol Section:
NCT00055159